Altavera

Levonorgestrel and Ethinyl Estradiol · Kit

Prescription (Rx) 1 recall

Boxed warning. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Altavera, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].

Uses

Altavera is indicated for use by females of reproductive potential to prevent pregnancy.

Description

Altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.

How supplied

Altavera tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/30 mcg) are available in a carton containing three blister cards, each containing 28 tablets: 21 Active Tablets: Peach, round, unscored, debossed with SZ on one side and J4 on the other side. 7 Inert Tablets: White, round, unscored, debossed with SZ on one side and J1 on the other side. 1 individual blister NDC 70700-116-84 Carton with 3 blisters NDC 70700-116-85 Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. ALTAVERA is a registered trademark of Xiromed Pharma España, S.L. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC., Florham Park, NJ 07932 Product of Spain PI-116-06 Rev. 02/2023

Label text from the FDA structured product label by Xiromed, LLC. (revised Feb 10, 2023). Long sections are shortened; the complete label is on DailyMed.

Altavera NDC products (2)

NDC	Strength & form	Labeler	Type
63629-2343	Kit	Bryant Ranch Prepack	ANDA
70700-116	Kit	Xiromed, LLC.	ANDA

Altavera recalls

D-0016-2019 Oct 17, 2018 · Class III · Terminated
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.

Frequently asked questions

What is Altavera used for?

Altavera is indicated for use by females of reproductive potential to prevent pregnancy.

Who makes Altavera?

Altavera is listed by 2 labelers in the FDA NDC directory, including Bryant Ranch Prepack, Xiromed, LLC..

Has Altavera been recalled?

The FDA enforcement database lists 1 recall for Altavera, most recently D-0016-2019 (class iii): Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.